Maribavir prophylaxis for prevention of cytomegalovirus disease in recipients of allogeneic stem-cell transplants: a phase 3, double-blind, placebo-controlled, randomised trial

CMV: Prevention, Diagnosis and Therapy

“…Maribavir is an orally administered benzimidazole L-riboside that is a potent inhibitor of the CMV UL97 kinase (120,121) and while a phase II trial of maribavir as prophylaxis after stem cell transplant showed significant reduction of active CMV infection (122), phase III trials found that maribavir had similar outcomes compared to placebo (123) and a stage III trial in liver transplant recipients was halted. Maribavir has been used as salvage therapy in very limited number of cases of multidrug resistant CMV infection (124).…”

Treatment of CMV infection after allogeneic hematopoietic stem cell transplantation

“…Strengthened by encouraging results from a phase II study [60] and granted fast track status drug, MBV was tested in a subsequent multicenter, randomized, double blind, phase III study, conducted on 681 HSCT patients. Rather surprisingly, it failed to demonstrate superior efficacy to prevent CMV disease as compared with to placebo [63]. Explanations may partly be due to the choice to adopt CMV end organ disease as the primary study endpoint and the exclusions of parameters such as viral load or start of pre-emptive therapy, the exclusion of high risk patients, the possibly too low dose of MBV (100 mg twice daily) employed [64,65].…”

Immunotherapy for viral and fungal infections

“…Current data reveal that serotherapy with anti-thymocyte globulin or Campath as well as the occurrence of severe acute GvHD and also SCT from an alternative donor or a mismatched related or unrelated donor is associated with an increased risk for an EBV-related lymphoproliferative disorder. 4 It is now appreciated that T-cell reconstitution is required for the sustained control of CMV, EBV and ADV infections 5,6 and that drug therapy limits the infection, but cannot prevent concurrent reactivations and may induce major toxicity (hematotoxicity/ nephrotoxicity/secondary infections).…”